Pharmaceutical compositions containing cannabis, uses thereof and methods for improving energy levels and/or alleviating fatigue

ABSTRACT

A pharmaceutical composition containing Cannabis for increasing energy levels and/or alleviating fatigue in a patient. Also provided are a use of the pharmaceutical composition for increasing energy levels and/or alleviating fatigue in a patient, and methods for increasing energy levels and/or alleviating fatigue. The pharmaceutical composition preferably includes a combination of therapeutically effective amounts of one or more of the following medicinal ingredients: Cannabis, an herb, vitamins, and/or fructose.

CROSS-REFERENCE TO RELATED APPLICATIONS

The present application is a divisional application of U.S. applicationSer. No. 16/734,681, filed Jan. 6, 2020. U.S. application Ser. No.16/734,681 is a continuation application of U.S. application Ser. No.16/375,938, filed on Apr. 5, 2019 and issued as U.S. Pat. No. 10,568,920on Feb. 25, 2020. U.S. application Ser. No. 16/375,938 claims priorityto Canadian application number 3000495, filed on Apr. 6, 2018. Theentire content of each of the referenced cited above are incorporatedherein by reference.

FIELD OF THE INVENTION

The present invention relates to pharmaceutical compositions comprisingCannabis and methods for improving energy and/or alleviating fatigue.

BACKGROUND OF THE INVENTION

There are an increasing number of patients who describe themselves asfeeling fatigue often. Fatigue can be due to physical fatigue associatedwith excess activity or working out and mental fatigue associated withsleep deprivation, depression, boredom, jet lagged and stress. Mentalfatigue does give the subjective feeling of physical fatigue. Fatiguealso is commonly caused by many medical conditions such as thyroiddisease, heart disease, chronic obstructive pulmonary disease (COPD),anemia, and infectious diseases such as the flu.

Many individuals do not receive treatment for fatigue as they have nothad the cause of the symptoms diagnosed. The prevalence in Ireland isestimated at 25%. (See: Cullen W, Kearney Y, Bury G. Prevalence offatigue in general practice. Ir J Med Sci, 2002 January-March;171(1):10-2)

As common as the disorder is, the number of treatment options islimited. Usually if it is a treatable medical condition such as anemiaor a limited disease state such as the flu, patients have the underlyingpathology treated with time, rehydration and rest. Similarly, insituations where it is physical fatigue patients can their symptomsimproved by rest, rehydration and eating a balanced diet. However, manypatients who suffer from mental fatigue have a more challenging timegetting relief from the symptoms of fatigue.

In addition, drugs and alcohol also are known contributors to fatigue.For example, Cannabis is a drug that can cause or contribute to fatigueat higher doses and when formulated with lower levels of THC(tetrahydrocannabinol) or less than about 10 mg of THC.

What may be needed is a pharmaceutical composition of Cannabis thattreats low energy levels and/or fatigue while minimizing associatedadverse effects.

SUMMARY OF THE INVENTION

According to an aspect of the present invention, there is disclosed apharmaceutical composition for increasing energy level and/oralleviating fatigue in a patient while minimizing side effects. Thepharmaceutical composition may preferably, but need not necessarily,comprise alone or in combination, therapeutically effective amounts ofCannabis and/or herbs for use as a medicinal product prescribed by aphysician, a health care practitioner or an over-the-counter productavailable at pharmacies, marijuana dispensaries and/or mass food stores.

According to an aspect of the invention, there is preferably disclosed apharmaceutical composition for increasing energy level and/oralleviating fatigue in a patient while minimizing side effects. Thepharmaceutical composition may preferably, but need not necessarily,additionally comprise therapeutically effective amounts of Camelliasinesis.

According to an aspect of the invention, there is preferably disclosed apharmaceutical composition for increasing energy level and/oralleviating fatigue in a patient while minimizing side effects. Thepharmaceutical composition may preferably, but need not necessarily,additionally comprise therapeutically effective amounts of Paulliniacupana (also known as guarana or Brazilian coca).

According to an aspect of the invention, there is preferably disclosed apharmaceutical composition for increasing energy level and/oralleviating fatigue in a patient while minimizing side effects. Thepharmaceutical composition may preferably, but need not necessarily,additionally comprise therapeutically effective amounts of Folate.

According to an aspect of the invention, there is preferably disclosed apharmaceutical composition for increasing energy level and/oralleviating fatigue in a patient while minimizing side effects. Thepharmaceutical composition may preferably, but need not necessarily,additionally comprise therapeutically effective amounts of Vitamin B12.

According to an aspect of the invention, there is preferably disclosed apharmaceutical composition for increasing energy level and/oralleviating fatigue in a patient while minimizing side effects. Thepharmaceutical composition may preferably, but need not necessarily,additionally comprise therapeutically effective amounts of Fructose.

According to an aspect of the invention, there is preferably disclosed apharmaceutical composition for increasing energy level and/oralleviating fatigue in a patient while minimizing side effects. Thepharmaceutical composition may preferably, but need not necessarily,comprise therapeutically effective amounts of Cannabis in any of thefollowing form cannabidiol (CBD), cannabidiol acid (CBDA), cannabinol(CBN), cannabigerol (CBG), cannabigerol acid (CBGA), cannabidivarin(CBDV), cannabidivarin acid (CBDVA), cannabinovarin (CBNV),cannabigerovarin (CBGV), cannabichromene (CBC), a naphthoylindole, aphenylacetylindole, a benzoylindole, a cyclohexylphenole, delta-9tetrahydrocannabinol (THC or dronabinol), delta-8 tetrahydrocannabinol(D8-THC), tetrahydrocannabinol acid (THCA), tetrahydrocannabivarin(THCV), tetrahydrocannabivarin acid (THCVA), the pharmaceutical agent isCBD, THC or a combination thereof.

According to an aspect of the invention, there is preferably disclosed apharmaceutical composition for increasing energy levels and/oralleviating fatigue in a patient. The pharmaceutical composition maypreferably, but need not necessarily, comprise a pharmaceuticallyacceptable excipient selected from any of the group consisting of:hydroxypropylcellulose, starch, silicon dioxide, gelatin, magnesiumstearate, or microcrystalline cellulose.

According to an aspect of the invention, there is preferably disclosed apharmaceutical composition for increasing energy levels and/oralleviating fatigue in a patient. The pharmaceutical composition maypreferably, but need not necessarily, comprise the form of a tablet,caplet, capsule, dermal patch, oil drops, powder or a suspension.

Other advantages, features and characteristics of the present invention,as well as methods of use and applications of the related elements ofthe pharmaceutical composition and formulation will become more apparentupon consideration of the following detailed description and theappended claims, the latter of which are briefly described hereinbelow.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

The description that follows, and the embodiments described therein, isprovided by way of illustration of an example, or examples, ofparticular embodiments of the principles and aspects of the presentinvention. These examples are provided for the purposes of explanation,and not of limitation, of those principles and of the invention.

It should also be appreciated that the present invention can beimplemented in numerous ways, including as a use of the pharmaceuticalcomposition or a method for increasing energy levels and/or alleviatingfatigue in a patient. In this specification, these implementations, orany other form that the invention may take, may be referred to as usesor methods. In general, the order of the steps of the disclosed methodsmay be altered within the scope of the invention.

In this disclosure, a number of terms are used. The followingdefinitions of such terms are provided.

As used herein, a person skilled in the relevant art may generallyunderstand the term “comprising” to generally mean the presence of thestated features, integers, steps, or components as referred to in theclaims, but that it does not preclude the presence or addition of one ormore other features, integers, steps, components or groups thereof.

As used herein, the skilled reader may generally understand the term“energy” or “energetic” to generally mean to possess, exert, or displaythe ability to do physical work. It is the ability and strength to doactive physical things and a feeling of physical power and life.

As used herein, the skilled reader may generally understand the term“fatigue” to generally mean a feeling of tiredness which is distinctfrom weakness and has a gradual onset. Fatigue can have physical ormental causes. Physical fatigue is the transient inability of a muscleto maintain optimal physical performance. Mental fatigue is a transientdecrease in maximal cognitive performance resulting from prolongedperiods of cognitive activity and can manifest as somnolence, lethargyor directed attention fatigue.

As used herein, a person skilled in the relevant art may generallyunderstand the term “treatment” to generally refer to an approach forobtaining beneficial or desired results. Beneficial or desired resultscan include, but are not limited to, prevention or prophylaxis,alleviation or amelioration of one or more symptoms or conditions,diminishment of the extent of a disease, stabilized (i.e., notworsening) state of disease, preventing spread of disease, delay orslowing of disease progression, amelioration or palliation of thedisease state, and remission (whether partial or total), whetherdetectable or undetectable. “Treatment” can also mean prolongingsurvival as compared to expected survival if not receiving treatment.

As used herein, a person skilled in the relevant art may generallyunderstand the term “therapeutically effective amount” to be an amountsufficient to effect treatment when administered to a subject in need oftreatment. In the case of the embodiments of the present invention, atherapeutically effective amount can include, but is not limited to, anamount for increasing energy levels and/or alleviating fatigue in apatient.

It will be understood by a person skilled in the relevant art that thecompositions of the present invention can be formulated intopharmaceutical compositions for administration in a manner customary foradministration of such materials using standard pharmaceuticalformulation chemistries and methodologies, all of which are readilyavailable to a person skilled in the relevant art. It will also beunderstood by a person skilled in the relevant art that suchpharmaceutical compositions may include one or more excipients,carriers, stabilizers or other pharmaceutically inactive compounds, suchas, but not limited to, wetting or emulsifying agents, pH bufferingsubstances, hydroxypropylcellulose, starch, silicon dioxide, gelatin,magnesium stearate, microcrystalline cellulose and the like.Pharmaceutically acceptable salts can also be included therein. Athorough discussion of pharmaceutically acceptable excipients, vehiclesand auxiliary substances is available in Remington's. PharmaceuticalSciences (Mack Pub. Co. N.J. 1991). Such pharmaceutical compositions canbe prepared as oral or transdermal preparations. The therapeuticallyeffective doses may vary according to body weight and the timing andduration of administration will be determined by specific clinicalresearch protocols.

It will be understood by a person skilled in the relevant art that theterm “dose” refers to the measured quantity of an agent, preferably atherapeutic agent, to be taken at one time to have a desired therapeuticeffect(s). Preferably, “dose” as used herein means a specified quantityof a pharmaceutical or therapeutic agent provided in one or moreadministration. It will be further understood that a “dosage unit” or“dosage form” as used herein means a form in which the active agent isprovided. It will be understood that any known dosage form may beemployed with the present invention. These may include, solid dosageforms, liquid dosage forms, gel dosage forms, etc. The term “effectivedose” or “effective dosage” is defined as an amount sufficient toachieve or at least partially achieve the desired effect. The term“therapeutically effective dose” is defined as an amount sufficient tocure or at least partially arrest the disease and/or one or moreassociated symptoms in a patient already suffering from the disease.

It will be understood by a person skilled in the relevant art that theterm “administering” means providing a therapeutically active agent orcomposition to a subject, and includes, but is not limited to,administering by a medical professional and self-administering.

It will be understood by a person skilled in the relevant art that a“pharmaceutical agent” or “therapeutic agent” as used herein means asubstance that provides a therapeutic effect when administered to asubject. “Pharmaceutical composition” means a mixture of substancessuitable for administering to an individual that includes one or morepharmaceutical or therapeutically effective agents. The terms “activepharmaceutical ingredient” shall be understood to refer to a substancein a pharmaceutical composition that provides a desired effect.

The treatment of low energy levels and/or fatigue in accordance with thepresent invention and as hereinafter defined for the purposes of thisinvention is directed to the improvement of energy levels and/oralleviating fatigue—including or in particularly mental fatigue—asdefined herein. In a preferred embodiment of the present invention, anagent or agents which can treat low energy levels and/or fatigue isrecommended. Since no pharmaceutical composition containing Cannabis ispresently capable of treating low energy levels and/or fatigue, apharmaceutical composition such as is described in the present inventionis recommended. Preferred embodiments of the present invention treat lowenergy levels and/or fatigue.

Preferably, the pharmaceutical compositions of the present invention maybe provided with different active ingredients, different strengthsand/or different formulations. Preferably, the pharmaceuticalcomposition of the present invention comprises a therapeuticallyeffective amount of Cannabis. A person skilled in the relevant art wouldunderstand the term “Cannabis” to refer to a genus of flowering plantsin the family Cannabaceae which produce a group of chemicals calledcannabinoids that produce physiological effects when administered to apatient. Persons skilled in the art will also readily appreciate that acannabinoid is one of a class of diverse chemical compounds that acts oncannabinoid receptors (e.g., cannabinoid receptor type 1, cannabinoidreceptor type 2) in cells that alter neurotransmitter release in thebrain. In accordance with one or more preferred embodiments of theinvention, the pharmaceutical composition may comprise Cannabis-derivedcannabinoids selected from the group consisting of: cannabidiol (CBD),cannabidiol acid (CBDA), cannabinol (CBN), cannabigerol (CBG),cannabigerol acid (CBGA), cannabidivarin (CBDV), cannabidivarin acid(CBDVA), cannabinovarin (CBNV), cannabigerovarin (CBGV), cannabichromene(CBC), a naphthoylindole, a phenylacetylindole, a benzoylindole, acyclohexylphenole, delta-9 tetrahydrocannabinol (THC or dronabinol),delta-8 tetrahydrocannabinol (D8-THC), tetrahydrocannabinol acid (THCA),tetrahydrocannabivarin (THCV), tetrahydrocannabivarin acid (THCVA), thepharmaceutical agent is CBD, THC or combinations thereof. In accordancewith an aspect of the present invention, compositions comprising atherapeutically effective amount of Cannabis may preferably serve toincrease energy level and/or alleviate fatigue in a patient. Inaccordance with some embodiments of the present invention, Cannabis maybe present in the composition in a particulate form with at least 50% bywt of the particles ranging in size from about 50 micron to about 2000micron and wherein the particles comprise a cannabinoid, cannabinoidderivative, a terpene or a mixture thereof in a range of 1 to 30 mg ofcannabinoid (CBD or THC) and most preferably from about 2.5 mg to about10 mg per dose.

The pharmaceutical composition of the present invention may alsocomprise a therapeutically effective amount of one or more herbs,including but not limited to: Camellia sinensis; Paullinia cupana; andcombinations thereof.

In a preferred embodiment, the pharmaceutical composition of the presentinvention comprises a therapeutically effective amount of Camelliasinensis (green tea). Persons skilled in the relevant art wouldunderstand the term “Camellia sinensis” to be a species of evergreenshrub or small tree whose leaves and leaf buds are used to produce tea.Persons skilled in the art will appreciate that Camellia sinensis hasbeen used in Asia for medicinal purposes for thousands of years. In theprior art, it is typically consumed as a beverage and is available as aliquid extract, capsules, tablets and as topical products. It has beenreported for use in cancers and heart disease to provide protectiveeffects. Camellia sinensis may also act as a stimulant and cantemporarily alleviate the feeling of fatigue and increase anindividual's energy level. (See: NIH.gov Fact sheet Green Tea) Inaccordance with the present invention, compositions comprising atherapeutically effective amount of Camellia sinensis may preferablyserve to increase energy level and/or alleviate fatigue in a patient. Inaccordance with some embodiments of the present invention, Camelliasinensis may be present in the composition from about 10 mg to about 500mg per dose and most preferably from about 100 mg to about 200 mg perdose.

In a preferred embodiment, the pharmaceutical composition of the presentinvention comprises a therapeutically effective amount of Paulliniacupana (also known as guarana or Brazilian coca). Persons skilled in therelevant art would understand the term “Paullinia cupana” to be aclimbing plant in the maple family, Sapindaceae, native to the Amazonbasin and common to Brazil having large leaves and clusters of flowers,best known for the seeds from its fruit which are about the size of acoffee bean. Persons skilled in the art will also appreciate thatPaullinia cupana is a seed that contains more caffeine than coffee beansand is known as a stimulant. The plant thrives in the Amazon rainforest.It has been reported to have various health benefits such as an abilityto ameliorate heat stroke, cardiovascular aid, increase mental focus andacuity and some analgesic qualities. (See: Rafael de Lima Portella,Romulo Pillon Barcelos and Felix Alexandre Antunes Soares, Guarana(Paullinia cupana Kunth) effects on LDL oxidation in elderly people: anin vitro and in vivo study. Lipids Health Dis. 2013; 12:12) Inaccordance with the present invention, compositions comprising atherapeutically effective amount of Paullinia cupana may preferablyserve to increase energy level and/or alleviate fatigue in a patient. Inaccordance with some embodiments of the present invention, Paulliniacupana may be present in the composition from about 25 mg to about 1000mg per dose and most preferably from about 100 mg to about 200 mg perdose.

In a preferred embodiment, the pharmaceutical composition of the presentinvention comprises a therapeutically effective amount of folate (folicacid). A person skilled in the relevant art would understand that theterm “folate” may comprise many forms of the vitamin—namely folic acidand its congeners, including tetrahydrofolic acid,methyltetrahydrofolate, methenylterahydrofolate, folinic acid, andfolacin. In the prior art, folate is considered part of the B vitaminsand can be found in forms such as folic acid or vitamin B9. Personsskilled in the art will also appreciate that folate is found in food anddietary supplements and is considered an essential vitamin since humansare not able to synthesize vitamin B9. Folate deficiency is known toresult in anemia and can cause the feeling of being tired. Folatedeficiency occurs in 1 in 10 people in the elderly patient populationaccording to the NHS in the United Kingdom. A paper published inNeurology in 1993 by Dr. Jacobson showed that patients with chronicfatigue also had an increase incidence of Folate deficiency.Supplementing with Folate has been reported to help correct thedeficiency and improve fatigue. In accordance with an aspect of thepresent invention, compositions comprising a therapeutically effectiveamount of folate may preferably serve to increase energy level and/oralleviate fatigue in a patient. In accordance with some embodiments ofthe present invention, folate may be present in the composition fromabout 25 mcg to about 2000 mcg per dose and most preferably from about250 mcg to about 400 mcg per dose.

In a preferred embodiment, the pharmaceutical composition of the presentinvention comprises a therapeutically effective amount of Vitamin B12(Cobalamin). A person skilled in the relevant art would understand that“Vitamin B12” is a coenzyme involved in the metabolism of cells of thehuman body, especially affecting DNA synthesis and regulation, but alsofatty acid metabolism and amino acid metabolism. Persons of skill in therelevant art will also appreciate that Vitamin B12 is a water solublevitamin that is essential for red blood cell formation, nerve functionand DNA production. It is reported to be found in foods such as poultry,meat, fish and dairy products. Deficiency of Vitamin B12 is more commonin vegans. Supplementation of Vitamin B12 orally or with IV infusionshas been shown to correct this problem and alleviates fatigue. (See:Mayoclinic.org) In accordance with the present invention, compositionscomprising a therapeutically effective amount of Vitamin B12 maypreferably serve to increase energy level and/or alleviate fatigue in apatient. In accordance with some embodiments of the present invention,Vitamin B12 may be present in the composition from about 250 mcg toabout 2000 mcg per dose and most preferably from about 450 mcg to about550 mcg per dose.

In a preferred embodiment, the pharmaceutical composition of the presentinvention comprises a therapeutically effective amount of Fructose. Aperson skilled in the relevant art would understand that “Fructose” is asimple ketonic monosaccharide found in plants and is a sugar. Personsskilled in the relevant art will also understand that once ingested, thesugar is readily absorbed into the bloodstream during the digestionprocess, which allows the fructose molecule to enter the blood streamand make its way to the liver where it is metabolized into glucose.Skilled readers will understand that glucose is the body's primaryenergy source and contributes to improvement of energy levels andalleviating fatigue. In accordance with an aspect of the presentinvention, compositions comprising a therapeutically effective amount ofFructose may preferably serve to increase energy level and/or alleviatefatigue in a patient. In accordance with some embodiments of the presentinvention, Fructose may be present in the composition from about 25 mgto about 100 mg per dose and most preferably from about 30 mg to about70 mg per dose.

In a preferred embodiment of the present invention, the combination ofCannabis with herbs, vitamins and/or fructose provides advantageousoutcomes as the pharmaceutical composition retains the therapeuticbenefits of Cannabis on relaxation to enable re-energization whileminimizing its potential adverse effects.

The pharmaceutical composition may preferably, but need not necessarily,be administered in a single or multiple doses prior to bed time toincrease energy levels and/or alleviate fatigue. In preferable,embodiments, a dose is taken once daily or up to four (4) times daily.In a preferred embodiment, a dosing regimen is continued until thefeeling of low energy and/or fatigue has abated. In some embodiments,the composition of the present invention may be administered once dailyto prevent low energy levels and/or fatigue.

In a preferred embodiment, the pharmaceutical composition of the presentinvention is used as a nutritional supplement to help patients whosuffer from decrease energy and/or increased fatigue. The pharmaceuticalcomposition of the present invention will preferably increase the energylevel of patients and/or minimize the feeling of fatigue. Preferably,the disorders that may be treated by embodiments of the presentinvention include, but are not limited to, fatigue, lethargy, listlesstiredness, malaise, feeling of being run down, worn out, chronic fatiguesyndrome, and symptoms caused by treatable medical disorders. Thepharmaceutical composition of the present invention is preferablyformulated in multiple strengths to treat the symptoms associated withthe above disorders. The pharmaceutical composition of the presentinvention is preferably formulated to use the minimal therapeuticallyeffective doses of the active ingredients to maximize absorption in thegastrointestinal track (e.g., maximize bioavailability) and minimizeside effects. In accordance with a preferred embodiment of the presentinvention, the pharmaceutical composition allows for a reduction in thedose of Cannabis required to achieve the same therapeutic effectcompared to Cannabis administered to a patient in a traditional dosageform (e.g., smoking or inhalation).

In accordance with a preferred embodiment of the present invention, thepharmaceutical composition is formulated to contain Cannabis comprisinga higher dose of THC (delta-9-tetrahydrocannabinol) or at least 2 mg THCper dose or more preferably at least 10 mg THC per dose. An advantage ofsuch formulations is to prevent the onset of, or contribution to,Cannabis-induced fatigue which has been reported to occur with higherdoses of Cannabis.

In accordance with a preferred embodiment of the present invention, theadministration of lower doses of Cannabis (compared to Cannabisadministered in a traditional dosage form, for example, smoking orinhalation) combined with the herbs, vitamins and fructose disclosedherein is advantageous as it provides a therapeutic effect on improvingenergy levels and/or alleviating fatigue and a reduction in cravings forfurther Cannabis that chronic Cannabis users may experience.

In accordance with a preferred embodiment of the present invention, thecombination of Cannabis, herbs, vitamins and/or fructose disclosedherein is advantageous as it may provide an unexpected synergistictherapeutic effect on improving energy levels and/or alleviatingfatigue.

In accordance with a preferred embodiment of the present invention, thecombination of Cannabis, herbs, vitamins and/or fructose disclosedherein is advantageous as it may unexpectedly allow for the use of alower dose of Cannabis to achieve a similar therapeutic effect whencompared to Cannabis administered to a patient in a traditional dosageform (e.g., smoking or inhalation).

In accordance with a preferred embodiment of the present invention, thecombination of Cannabis, herbs, vitamins and/or fructose disclosedherein is advantageous as it may allow for the use of a lower dose ofCannabis to reduce the severity and/or number of potentialCannabis-related adverse effects.

The pharmaceutical composition of the present invention is a formulationcomprising Cannabis in addition to various herbs, vitamins and fructose,either used as a medicine prescribed by a physician, a health carepractitioner, or an over-the-counter product available in pharmacies,marijuana dispensaries, and mass food stores and will preferably helppatients who suffer from sleeping disorders achieve more energy.

In accordance with a preferred embodiment of the present invention, thepharmaceutical composition comprising Cannabis, herbs, vitamins andfructose may be administered once or up to four (4) times daily prior tobedtime during periods of low energy and/or fatigue. The pharmaceuticalcomposition of the present invention delivers high concentrations ofseveral herbs and vitamins including Camellia sinensis, Paulliniacupana, Folate, Vitamin B12 (cobalamin), fructose and therapeuticallyeffective concentrations of Cannabis in any form without causingincreased side effects. The combination of the foregoing herbs,vitamins, fructose and Cannabis in a single formulation to increaseenergy level and/or alleviate fatigue in a patient is unique and has notbeen previously described.

Persons skilled in the relevant art may find it counterintuitive to findthat Cannabis may improve energy levels when it has been reported tocause sleepiness. In accordance with preferred embodiments of thepresent invention, however, Cannabis administered in predetermined dosesin combination with the supplements described herein allows for the bodyto relax and be re-energized. The pharmaceutical composition of thepresent invention is formulated to provide seemingly paradoxical effectsas the predetermined therapeutically effective dose of Cannabis providespatients with an increase in energy level.

Example 1

The following example sets out a preferred formulation of thepharmaceutical composition in accordance with the present invention toincrease energy level and/or alleviate fatigue in a patient.

Medicinal Ingredients Quantity Camellia sinensis 156.5 mg Folate 300.0mcg Fructose  50.0 mg Paullinia cupana 170.4 mg Vitamin B12 500.0 mcgCannabis (THC) 0.05 g to 2 g of 10% to 50% THC levels

In preferred embodiments of the invention, the formulation is allergenfree (e.g., egg products, wheat (gluten) and dairy (lactose)). Inaddition, all compounds in the formulation are preferably gluten free.

Example 2

Background:

A test formulation comprising a combination of Camellia sinensis (156.5mg), folate (300.0 mcg), Fructose (50.0 mg), Paullinia cupana (170.4mg), Vitamin B12 (500.0 mcg), and Cannabis (THC) (0.05 g to 2 g of 10%to 50% THC levels) was prepared in a capsule dosage form to study theeffectiveness of the combination on increasing energy level and/oralleviating fatigue in a patient.

Objective:

To assess whether the test formulation described above is effective inthe increase of energy level and/or reduction of fatigue in a patient.

Methods:

A 30 year old male experiences anxiety and suffers from decreasedenergy. The subject was administered the capsule formulation twice dailyfor two weeks and then qualitatively assessed for energy level andfatigue.

Results:

The subject experienced greater energy levels and lower anxiety andfatigue. No obvious adverse effects of the test formulation wereidentified.

Conclusions:

The test formulation may be effective to increase energy levels and/oralleviate fatigue in a patient. Further studies may be needed toqualitatively and/or quantitatively assess improvement in energy levelsand reduction in fatigue and to determine the preferred medicinalingredients (including the preferred quantity of each) to include in thecomposition as well as the potential adverse effects associated withsame.

The above description is meant to be exemplary only, and one skilled inthe art will recognize that changes may be made to the embodimentsdescribed without departing from the scope of the invention disclosed.Modifications which fall within the scope of the scope of the presentinvention will be apparent to those skilled in the art, in light of areview of this disclosure, and such modifications are intended to fallwithin the appended claims.

This concludes the description of presently preferred embodiments of theinvention. The foregoing description has been presented for the purposeof illustration and is not intended to be exhaustive or to limit theinvention to the precise form disclosed. Other modification, variationsand alterations are possible in light of the above teaching and will beapparent to those skilled in the art, and may be used in the design andmanufacture of other embodiments according to the present inventionwithout departing from the spirit and scope of the invention. It isintended the scope of the invention be limited not by this descriptionbut only by the claims forming a part hereof.

What is claimed is:
 1. A tablet, caplet, capsule or dermal patchconsisting of a Cannabis extract, a Paullinia cupana extract: VitaminB9, Vitamin B 12 and fructose.
 2. The tablet, caplet, capsule or dermalpatch of claim 1 wherein the tablet, caplet, capsule or dermal patchconsists of from about 25 mg to about 1000 mg of the Paullinia cupanaextract per dose.
 3. The tablet, caplet, capsule or dermal patch ofclaim 2 wherein the tablet, caplet, capsule or dermal patch consists offrom about 100 mg to about 200 mg of the Paullinia cupana extract perdose.
 4. The tablet, caplet, capsule or dermal patch of claim 1 whereinthe tablet, caplet, capsule or dermal patch consists of from about 1 mgto about 30 mg of the Cannabis extract per dose.
 5. The tablet, caplet,capsule or dermal patch of claim 4 wherein the tablet, caplet, capsuleor dermal patch consists of from about 2.5 mg to about 10 mg of theCannabis extract per dose.
 6. The tablet, caplet, capsule or dermalpatch of claim 1 wherein the tablet, caplet, capsule or dermal patchconsists of from about 25 mcg to about 2000 mcg of Vitamin B9 per dose.7. The tablet, caplet, capsule or dermal patch of claim 6 wherein thetablet, caplet, capsule or dermal patch consists of from about 250 mcgto about 400 mcg of Vitamin B9 per dose.
 8. The tablet, caplet, capsuleor dermal patch of claim 1 wherein the tablet, caplet, capsule or dermalpatch consists of from about 250 mcg to about 2000 mcg of Vitamin B 12per dose.
 9. The tablet, caplet, capsule or dermal patch of claim 8wherein the tablet, caplet, capsule or dermal patch consists of fromabout 450 mcg to about 550 mcg of Vitamin B 12 per dose.
 10. The tablet,caplet, capsule or dermal patch of claim 9 wherein the tablet, caplet,capsule or dermal patch consists of from about 25 mg to about 100 mg ofthe fructose per dose.
 11. The tablet, caplet, capsule or dermal patchof claim 10 wherein the tablet, caplet, capsule or dermal patch consistsof from about 30 mg to about 70 mg of the fructose per dose.